FDA product code GBO: Catheter, Nephrostomy, General & Plastic Surgery
GBO is the FDA product code for catheter, nephrostomy, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel. FDA has cleared 11 510(k) submissions under GBO, from 6 different applicants. The average 510(k) review took 43 days (median 46). FDA has posted 8 recalls for GBO devices.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Nephrostomy, General & Plastic Surgery |
| Device class | Class I |
| Regulation | 21 CFR 878.4200 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GBO clearance
Top GBO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Angiomed U.S., Inc. | 5 | 1986-01-24 |
| Dow Corning Corp. Healthcare Industries Materials | 2 | 1979-01-22 |
| Uresil, LLC | 1 | 2004-08-19 |
| Uresil, L.P. | 1 | 2002-06-13 |
| Uresil Corp. | 1 | 1991-08-12 |
1 more applicants have GBO clearances. See the full list in Caduvo.
Most recent GBO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K041995 | Uresil, LLC | MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARY | 2004-08-19 | 27 |
| K021632 | Uresil, L.P. | GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE C | 2002-06-13 | 27 |
| K912109 | Uresil Corp. | URESIL GENERAL PURPOSE DRAINAGE CATHETER | 1991-08-12 | 91 |
| K854906 | Angiomed U.S., Inc. | PERCUTANEOUS NEPHROSTOMY SETS (OTTO) | 1986-01-24 | 0 |
| K854905 | Angiomed U.S., Inc. | PERCUTANEOUS NEPHROSTOMY SETS (LOOP TECHNIQUE) | 1986-01-24 | 46 |
Recalls for GBO devices
8 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-12-27.
| Year | Recalls |
|---|---|
| 2017 | 5 |
| 2019 | 1 |
Frequently asked questions
What is FDA product code GBO?
GBO is the FDA product code for catheter, nephrostomy, general & plastic surgery. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel.
What device class is GBO?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GBO?
Across 11 cleared submissions the average was 43 days from receipt to decision (median 46).
Which companies have the most GBO clearances?
Angiomed U.S., Inc. (5); Dow Corning Corp. Healthcare Industries Materials (2); Uresil, LLC (1); Uresil, L.P. (1); Uresil Corp. (1).
Have GBO devices been recalled?
Yes: 8 product recalls across 4 recall events; the most recent began 2019-12-27.
Next steps
- Run an FDA pathway report with predicate devices for product code GBO
- Run a recall and safety report across every GBO manufacturer
- Watch product code GBO for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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